Colorectal CancerPhase 1NCT07300150
A Study of PT0511 in Participants With KRAS Mutated or Amplified Advanced Solid Tumors
A Phase 1 study testing PT0511 and Cetuximab in people with Colorectal Cancer and Pancreatic Cancer, run by PAQ Therapeutics, Inc. at 9 sites in 2 countries.
Trial summary
The primary purpose of this study is to evaluate the safety and tolerability, determine the maximally tolerated dose (MTD) and/or recommended Phase 2 dose(s) (RP2D) of PT0511 in adult participants with solid tumors as monotherapy and in combination with cetuximab in participants with colorectal cancer (CRC). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer, Pancreatic Cancer, Non-Small Cell Lung Cancer
- What is being tested?
- PT0511 and Cetuximab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 9 sitesin 2 countries
- Study dates
- 21 Nov 2025to 18 Oct 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men or women less than or equal to (>=) 18 years of age
- Histologically or cytologically confirmed advanced or metastatic solid malignancy
- Participant has a pathologically documented, locally advanced or metastatic malignancy with any KRAS mutation or wild-type (WT) KRAS amplification identified through molecular testing using a Clinical Laboratory Improvement Amendments (CLIA) certified, validated institutional or commercial test
- Participant must have received at least 1 and no more than 4 prior systemic therapies or be intolerant or ineligible for available therapies known to provide clinical benefit
- Measurable disease (RECIST 1.1 Criteria)
- ECOG Performance Status 0 or 1
- Willingness to avoid pregnancy or fathering children screening through 90 days after the last dose of study treatment
Who cannot join
- Cancer History
- Active brain metastasis or carcinomatous meningitis. If participants have had brain metastases resected or have received radiation therapy, they may be eligible if: (1) study treatment begins at least 4 weeks from the end of brain-specific therapy, (2) residual neurological symptoms Grade <=2, (3) currently on stable doses of corticosteroids, and (4) pre-study brain MRI documents no new/worsening brain lesions
- History of any other malignancy within the past 2 years, except:
- Malignancy treated with curative intent and with no known active disease present >=2 years before enrolment and felt to be at low risk for recurrence by the investigator
- Basal or squamous cell carcinoma of the skin, in situ cervical cancer, early -stage endometrial cancer that has been definitively treated, superficial bladder cancer, Gleason 6/7 treated prostate cancer, and ductal carcinoma in situ or lobular carcinoma in situ of the breast
- Prior Cancer Therapy
Show all 33Show fewer
- Unresolved toxicities from prior anti-cancer therapies. Participants with prior endocrine replacement therapies are eligible for entry even if administered to treat endocrine deficiency due to the prior anti-cancer therapy
- Concurrent participation in another interventional clinical study.
- Treatment with anticancer medications or investigational drugs within the following intervals before the first administration of study drug:
- At least 14 days for chemotherapy or targeted small-molecule therapy
- At least 28 days for a prior monoclonal antibody
- At least 28 days or 5 half-lives (whichever is longer) for all other investigational study drugs or devices. For drugs with very long half-lives, participants may be allowed to enroll prior to 5 half-lives at the discretion of the investigator in discussion with the medical monitor
- Note: Concurrent hormonal therapy for prostate or breast cancer is allowable
- Prior treatment with a KRAS/RAS degrader
- Medical History
- Significant cardiovascular disease within 6 months of starting study therapy
- Active infection requiring antibiotics within 7 days of study treatment.
- Known HIV infection with a CD4+ T-cell count <200 cells/mcL and/or a detectable viral load per parameters of assay and/or on an anti-retroviral regimen containing a strong or moderate CYP3A4/5 inhibitor or inducer and/or on a new anti-retroviral regimen for less than 28 days prior to the initiation of study treatment
- Known history of drug-induced liver injury; primary biliary cirrhosis; or ongoing extrahepatic obstruction caused by stones, cirrhosis of the liver, or portal hypertension
- Major surgery within 4 weeks of the start of study therapy or postoperative complications preventing the participant from adhering to protocol assessments and procedures
- Known hypersensitivity to any of the products to be administered during dosing
- Any disease or disorder that, in the opinion of the investigator, may compromise the ability of the participant to provide written informed consent and/or to comply with all required study procedures
- Medications
- Part 1a (Dose escalation): Use of a strong or moderate CYP3A4/5 inhibitor or inducer, Use of a strong P-gp inhibitor or inducer
- Organ Function
- Participants with laboratory values indicating inadequate hematology, hepatic, or renal function
- Diagnostic Assessments
- Clinically significant abnormalities in rhythm, conduction, or morphology of resting ECG
- Baseline QT interval corrected for heart rate using Fridericia's formula (QTcF) >=470 msec
- Female participants of childbearing age with a positive urine or serum test within 7 days of study start or confirmation from Ob/Gyn that any positive bHCG test is not representative of an ongoing pregnancy
- Women who are lactating/breast feeding or who plan to breastfeed while on study through 28 days after receiving the last dose of study drug
- Active HBV infection. Participants with resolved infection or who are on Stable antiviral therapy are eligible
- Active HCV infection. Participants who have completed definitive antiviral therapy with post treatment confirmation of eradication are eligible
Trial locations and contacts
9 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
9 sites in 2 countries
United States5 sites, 5 recruiting
- Recruiting
Dana-Farber/Massachusetts General Hospital, Inc
Boston, Massachusetts, 02215
Leon Pappas, lpappas3@mgb.org
- Recruiting
NEXT Virginia
Fairfax, Virginia, 22031
Alexander Spira, aspira@nextoncology.com
- Recruiting
New Experimental Therapeutics of San Antonio LLC
San Antonio, Texas, 78229
Ildefonso Ismael Rodriguez Rivera, irodriguez@nextoncology.com
- Recruiting
START - South Texas Accelerated Research Therapeutics, LLC
San Antonio, Texas, 78229
Drew Rasco, drasco@startsa.com
- Recruiting
START Mountain Region
West Valley City, Utah, 84119
William McKean, william.mckean@startresearch.com
South Korea4 sites, 4 recruiting
- Recruiting
Samsung Medical Center
Seoul
JoonOh Park
- Recruiting
Seoul National University Bundang Hospital
Seoul
Jinwon kim
- Recruiting
Seoul National University Hospital
Seoul
Do-Youn Oh
- Recruiting
Severance Hospital, Yonsei University Health System
Seoul
HyeJin Choi
About this study
Official title: A Phase 1, Open-label Dose Escalation and Expansion Study Of PT0511 in Participants With KRAS Mutated OR Amplified Advanced Solid Tumors
The primary purpose of this study is to evaluate the safety and tolerability, determine the maximally tolerated dose (MTD) and/or recommended Phase 2 dose(s) (RP2D) of PT0511 in adult participants with solid tumors as monotherapy and in combination with cetuximab in participants with colorectal cancer (CRC).
- Being tested
- PT0511, Cetuximab
- Keywords
- KRAS
- Medical subject headings
- Colorectal Neoplasms, Pancreatic Neoplasms, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PT0511Drug
Intravenous infusion.
CetuximabDrug
Intravenous infusion.
| Study group | Role | What they receive |
|---|---|---|
| Part 1a: Dose Escalation | Experimental | Participants with solid tumors with any KRAS mutation or amplified WT KRAS will receive PT0511 infusion, intravenously (IV), until disease progression or intolerance. Receives: Drug: PT0511 |
| Part 1b: Dose Expansion: Tumor type 1 | Experimental | Participants with tumor type 1 will receive PT0511 infusion until disease progression or intolerance. Recommended dose or doses for expansion for Part 1b will be determined based on the safety, tolerability, pharmacokinetic (PK) and pharmacodynamic (PD) data for PT0511 established in Part 1a. Receives: Drug: PT0511 |
| Part 1b: Dose Expansion: Tumor type 2 | Experimental | Participants with tumor type 2 will receive PT0511 infusion in combination with cetuximab infusion, until disease progression or intolerance. Recommended dose or doses for expansion for Part 1b will be determined based on the safety, tolerability, PK and PD data for PT0511 established in Part 1a. Receives: Drug: PT0511; Drug: Cetuximab |
| Part 1b: Dose Expansion: Tumor type 3 | Experimental | Participants with tumor type 3 will receive PT0511 infusion until disease progression or intolerance. Recommended dose or doses for expansion for Part 1b will be determined based on the safety, tolerability, PK and PD data for PT0511 established in Part 1a. Receives: Drug: PT0511 |
| Part 1b: Dose Expansion: Tumor type 4 | Experimental | Participants with tumor type 4 will receive PT0511 infusion until disease progression or intolerance. Recommended dose or doses for expansion for Part 1b will be determined based on the safety, tolerability, PK and PD data for PT0511 established in Part 1a. Receives: Drug: PT0511 |
| Part 1b: Dose Expansion: Tumor type 5 | Experimental | Participants with tumor type 5 will receive PT0511 infusion until disease progression or intolerance. Recommended dose or doses for expansion for Part 1b will be determined based on the safety, tolerability, PK and PD data for PT0511 established in Part 1a. Receives: Drug: PT0511 |
| Part 1b: Dose Expansion: Tumor type 6 | Experimental | Participants with tumor type 6 will receive PT0511 infusion until disease progression or intolerance. Recommended dose or doses for expansion for Part 1b will be determined based on the safety, tolerability, PK and PD data for PT0511 established in Part 1a. Receives: Drug: PT0511 |
| Part 1b: Dose Expansion: Tumor type 7 | Experimental | Participants with tumor type 7 will receive PT0511 infusion until disease progression or intolerance. Recommended dose or doses for expansion for Part 1b will be determined based on the safety, tolerability, PK and PD data for PT0511 established in Part 1a. Receives: Drug: PT0511 |
| Part 1b: Dose Expansion: Tumor type 8 | Experimental | Participants with tumor type 8 will receive PT0511 infusion until disease progression or intolerance. Recommended dose or doses for expansion for Part 1b will be determined based on the safety, tolerability, PK and PD data for PT0511 established in Part 1a. Receives: Drug: PT0511 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Dose-limiting Toxicities (DLT)
Measured: Cycle 1 (Cycle length=21 days)
Number of Participants with Treatment-Emergent Adverse Events (TEAEs)
Measured: Up to 24 months
Number of Participants with TEAEs Leading to Treatment Interruptions, Dose Reductions and Permanent Discontinuations
Measured: Up to 24 months
Secondary outcomes (12)
Cmax/C0: Maximum Blood Concentration (Cmax) and/or Concentration at Time 0 (C0) of PT0511
Measured: Cycle 1 Days 1 and 15: Pre-infusion and up to 24 hours post-infusion (Cycle length=21 days)
Tmax: Time to Reach Cmax of PT0511
Measured: Cycle 1 Days 1 and 15: Pre-infusion and up to 24 hours post-infusion (Cycle length=21 days)
AUC0-t: Area Under the Curve From time 0 to the time of the Last Quantifiable Concentration of PT0511
Measured: Cycle 1 Days 1 and 15: Pre-infusion and up to 24 hours post-infusion (Cycle length=21 days)
t1/2: Terminal Elimination Half-life of PT0511
Measured: Cycle 1 Days 1 and 15: Pre-infusion and up to 24 hours post-infusion (Cycle length=21 days)
AUC0-∞: Area Under the Curve From Time 0 Extrapolated to Infinity of PT0511
Measured: Cycle 1 Days 1 and 15: Pre-infusion and up to 24 hours post-infusion (Cycle length=21 days)
CL: Clearance of PT0511
Measured: Cycle 1 Days 1 and 15: Pre-infusion and up to 24 hours post-infusion (Cycle length=21 days)
Vd: Volume of Distribution of PT0511
Measured: Cycle 1 Days 1 and 15: Pre-infusion and up to 24 hours post-infusion (Cycle length=21 days)
Overall Response Rate (ORR)
ORR will be determined by radiographic disease assessments per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
Measured: Up to 12 months
Duration of Response (DOR)
DOR will be determined by radiographic disease assessments per RECIST 1.1.
Measured: Up to 12 months
Number of Participants with Antitumor Activity Markers in Peripheral Blood of PT0511
Measured: Cycle 1 Day 15: Pre-infusion and up to 24 hours post-infusion (Cycle length=21 days)
Overall Survival (OS)
OS is defined as the time from enrollment up to death due to any cause.
Measured: At 1 year
Progression-free Survival (PFS)
PFS will be determined by radiographic disease assessments per RECIST 1.1.
Measured: At 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2025
- Study start21 Nov 2025
- Primary completion18 Oct 2028 (estimated)
- Study completion18 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- PAQ Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07300150
- Sponsor's protocol ID
- PT0511-101
- Status last verified
- Jul 2026
- First submitted
- 10 Dec 2025
- Last updated
- 6 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-label Dose Escalation and Expansion Study Of PT0511 in Participants With KRAS Mutated OR Amplified Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT07300150
- Acronym / sponsor ID
- PT0511-101
- Keywords
- KRAS
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- PAQ Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 21 Nov 2025 (actual)
- Primary completion
- 18 Oct 2028 (estimated)
- Study completion
- 18 Oct 2028 (estimated)
- First posted
- 23 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary purpose of this study is to evaluate the safety and tolerability, determine the maximally tolerated dose (MTD) and/or recommended Phase 2 dose(s) (RP2D) of PT0511 in adult participants with solid tumors as monotherapy and in combination with cetuximab in participants with colorectal cancer (CRC).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| Part 1a: Dose Escalation | Experimental | Drug: PT0511Participants with solid tumors with any KRAS mutation or amplified WT KRAS will receive PT0511 infusion, intravenously (IV), until disease progression or intolerance. |
| Part 1b: Dose Expansion: Tumor type 1 | Experimental | Drug: PT0511Participants with tumor type 1 will receive PT0511 infusion until disease progression or intolerance. Recommended dose or doses for expansion for Part 1b will be determined based on the safety, tolerability, pharmacokinetic (PK) and pharmacodynamic (PD) data for PT0511 established in Part 1a. |
| Part 1b: Dose Expansion: Tumor type 2 | Experimental | Drug: PT0511, Drug: CetuximabParticipants with tumor type 2 will receive PT0511 infusion in combination with cetuximab infusion, until disease progression or intolerance. Recommended dose or doses for expansion for Part 1b will be determined based on the safety, tolerability, PK and PD data for PT0511 established in Part 1a. |
| Part 1b: Dose Expansion: Tumor type 3 | Experimental | Drug: PT0511Participants with tumor type 3 will receive PT0511 infusion until disease progression or intolerance. Recommended dose or doses for expansion for Part 1b will be determined based on the safety, tolerability, PK and PD data for PT0511 established in Part 1a. |
| Part 1b: Dose Expansion: Tumor type 4 | Experimental | Drug: PT0511Participants with tumor type 4 will receive PT0511 infusion until disease progression or intolerance. Recommended dose or doses for expansion for Part 1b will be determined based on the safety, tolerability, PK and PD data for PT0511 established in Part 1a. |
| Part 1b: Dose Expansion: Tumor type 5 | Experimental | Drug: PT0511Participants with tumor type 5 will receive PT0511 infusion until disease progression or intolerance. Recommended dose or doses for expansion for Part 1b will be determined based on the safety, tolerability, PK and PD data for PT0511 established in Part 1a. |
| Part 1b: Dose Expansion: Tumor type 6 | Experimental | Drug: PT0511Participants with tumor type 6 will receive PT0511 infusion until disease progression or intolerance. Recommended dose or doses for expansion for Part 1b will be determined based on the safety, tolerability, PK and PD data for PT0511 established in Part 1a. |
| Part 1b: Dose Expansion: Tumor type 7 | Experimental | Drug: PT0511Participants with tumor type 7 will receive PT0511 infusion until disease progression or intolerance. Recommended dose or doses for expansion for Part 1b will be determined based on the safety, tolerability, PK and PD data for PT0511 established in Part 1a. |
| Part 1b: Dose Expansion: Tumor type 8 | Experimental | Drug: PT0511Participants with tumor type 8 will receive PT0511 infusion until disease progression or intolerance. Recommended dose or doses for expansion for Part 1b will be determined based on the safety, tolerability, PK and PD data for PT0511 established in Part 1a. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Men or women less than or equal to (>=) 18 years of age
- Histologically or cytologically confirmed advanced or metastatic solid malignancy
- Participant has a pathologically documented, locally advanced or metastatic malignancy with any KRAS mutation or wild-type (WT) KRAS amplification identified through molecular testing using a Clinical Laboratory Improvement Amendments (CLIA) certified, validated institutional or commercial test
- Participant must have received at least 1 and no more than 4 prior systemic therapies or be intolerant or ineligible for available therapies known to provide clinical benefit
- Measurable disease (RECIST 1.1 Criteria)
Key exclusion criteria (33 listed)
- Cancer History
- Active brain metastasis or carcinomatous meningitis. If participants have had brain metastases resected or have received radiation therapy, they may be eligible if: (1) study treatment begins at least 4 weeks from the end of brain-specific therapy, (2) residual neurological symptoms Grade <=2, (3) currently on stable doses of corticosteroids, and (4) pre-study brain MRI documents no new/worsening brain lesions
- History of any other malignancy within the past 2 years, except:
- Prior Cancer Therapy
- Unresolved toxicities from prior anti-cancer therapies. Participants with prior endocrine replacement therapies are eligible for entry even if administered to treat endocrine deficiency due to the prior anti-cancer therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PT0511Intravenous infusion. | Drug | Part 1a: Dose Escalation, Part 1b: Dose Expansion: Tumor type 1, Part 1b: Dose Expansion: Tumor type 2, Part 1b: Dose Expansion: Tumor type 3, Part 1b: Dose Expansion: Tumor type 4, Part 1b: Dose Expansion: Tumor type 5, Part 1b: Dose Expansion: Tumor type 6, Part 1b: Dose Expansion: Tumor type 7, Part 1b: Dose Expansion: Tumor type 8 |
| CetuximabIntravenous infusion. | Drug | Part 1b: Dose Expansion: Tumor type 2 |
Primary outcome
Number of Participants with Dose-limiting Toxicities (DLT)
Time frame: Cycle 1 (Cycle length=21 days)
Number of Participants with Treatment-Emergent Adverse Events (TEAEs)
Time frame: Up to 24 months
Number of Participants with TEAEs Leading to Treatment Interruptions, Dose Reductions and Permanent Discontinuations
Time frame: Up to 24 months
12 secondary outcomes
Cmax/C0: Maximum Blood Concentration (Cmax) and/or Concentration at Time 0 (C0) of PT0511
Time frame: Cycle 1 Days 1 and 15: Pre-infusion and up to 24 hours post-infusion (Cycle length=21 days)
Tmax: Time to Reach Cmax of PT0511
Time frame: Cycle 1 Days 1 and 15: Pre-infusion and up to 24 hours post-infusion (Cycle length=21 days)
AUC0-t: Area Under the Curve From time 0 to the time of the Last Quantifiable Concentration of PT0511
Time frame: Cycle 1 Days 1 and 15: Pre-infusion and up to 24 hours post-infusion (Cycle length=21 days)
t1/2: Terminal Elimination Half-life of PT0511
Time frame: Cycle 1 Days 1 and 15: Pre-infusion and up to 24 hours post-infusion (Cycle length=21 days)
AUC0-∞: Area Under the Curve From Time 0 Extrapolated to Infinity of PT0511
Time frame: Cycle 1 Days 1 and 15: Pre-infusion and up to 24 hours post-infusion (Cycle length=21 days)
CL: Clearance of PT0511
Time frame: Cycle 1 Days 1 and 15: Pre-infusion and up to 24 hours post-infusion (Cycle length=21 days)
Vd: Volume of Distribution of PT0511
Time frame: Cycle 1 Days 1 and 15: Pre-infusion and up to 24 hours post-infusion (Cycle length=21 days)
Overall Response Rate (ORR)
Time frame: Up to 12 months
Duration of Response (DOR)
Time frame: Up to 12 months
Number of Participants with Antitumor Activity Markers in Peripheral Blood of PT0511
Time frame: Cycle 1 Day 15: Pre-infusion and up to 24 hours post-infusion (Cycle length=21 days)
Overall Survival (OS)
Time frame: At 1 year
Progression-free Survival (PFS)
Time frame: At 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
9 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PT0511 and Cetuximab in people with Colorectal Cancer and Pancreatic Cancer, run by PAQ Therapeutics, Inc. at 9 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 33 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States, South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact PAQ Therapeutics (781-819-2949, ClinicalTrials@paqtx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Dose-limiting Toxicities (DLT) (time frame: Cycle 1 (Cycle length=21 days)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2026.